Penny K. Campbell

Telephone Coaching to Enhance a Home-Based Physical Activity Program for Knee Osteoarthritis: A Randomized Clinical Trial

To investigate whether simultaneous telephone coaching improves the clinical effectiveness of a physiotherapist‐prescribed home‐based physical activity program for knee osteoarthritis (OA).

Unloading Shoes for Self-management of Knee Osteoarthritis: A Randomized Trial.

Global estimates suggest that knee osteoarthritis affects 10% to 25% of women and 5% to 15% of men aged 60 years or older (1). It results in pain, physical dysfunction, and reduced quality of life and is a leading contributor to global disability (1). In the United States, osteoarthritis is the second most common nonacute reason for seeking medical advice after skin disorders (2). Because it has no cure, advice for self-management is the cornerstone of conservative treatment, along with exercise and weight control (3, 4). Given that abnormal biomechanics are critical to the pathogenesis of knee osteoarthritis (5, 6), clinical guidelines recommend appropriate footwear as part of core treatment (3, 7). However, there is scant evidence from clinical trials to guide footwear choice for this patient group or for any population with chronic musculoskeletal pain. Accordingly, both the European League Against Rheumatism (7) and the U.K. National Institute for Health and Care Excellence (3) have identified footwear trials as a research priority. Furthermore, a U.S. stakeholder panel recently identified evaluating the effectiveness of biomechanical strategies for osteoarthritis as a high-priority evidence gap (8). Abnormal knee load is important in the development and progression of knee osteoarthritis (5, 6) and probably explains why most tibiofemoral osteoarthritis occurs medially (9), given that medial compartment loading is greater than lateral compartment loading during walking (10). Wearing shoes increases medial knee load compared with being barefoot (11, 12), so recent research has focused on developing novel unloading shoes for persons with knee osteoarthritis to reduce medial knee load. Unloading shoes with soles that are stiffer laterally than medially significantly reduce medial knee loads via changes in foot and ankle biomechanics (1316) compared with shoes with conventional soles of uniform stiffness. These types of unloading shoes are now commercially available from footwear retailers (for example, ABEO SMARTsystem [The Walking Company] and GEL-Melbourne OA or GEL-Melo [ASICS]) and are recommended by the manufacturers for persons with knee pain or osteoarthritis. However, whether unloading shoes can reduce pain and physical dysfunction associated with knee osteoarthritis is unclear. In the only randomized, controlled trial (RCT) to date, unloading shoes with soles that were stiffer laterally than medially did not result in between-group differences in the primary pain outcome at 6 months (17) or 1 year (18), but they did lead to more persons achieving a clinically important reduction in pain than the control group (71% vs. 35% at 6 months). Given that persons with generally mild pain and radiographic disease were recruited as well as the considerable dropout rate (30% at 1 year), further clinical trials are required to definitively evaluate unloading shoes for knee osteoarthritis. The aim of this study was to evaluate the efficacy of unloading walking shoes in alleviating knee osteoarthritis symptoms. We hypothesized that unloading shoes would reduce pain and improve physical function after 6 months compared with conventional walking shoes. Methods Design Overview We conducted a 2-group, parallel-group, comparative effectiveness RCT. The protocol has been published (19). The trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12613000851763) and was approved by the Institutional Human Ethics Committee. Participants provided informed consent. Setting and Participants We recruited community-dwelling participants from Melbourne, Australia, between August 2013 and May 2015 via print, radio, television, and social media advertisements and our research database. Participants were included if they were aged 50 years or older, had knee pain on most days in the previous month, reported average pain of at least 4 on an 11-point numerical rating scale (NRS) (with terminal descriptors of no pain and worst pain possible) in the previous week, had radiographic evidence of osteoarthritis (KellgrenLawrence grade 2 [20]), and had definite medial tibiofemoral osteoarthritis on radiography (grade 1 medial osteophytes and grade 1 medial joint space narrowing that was greater than lateral [21]). Exclusion criteria were presence of lateral tibiofemoral osteophytes that were worse than medial (21); intra-articular corticosteroid injection or knee surgery in the prior 3 months; presence of a systemic arthritic condition; prior knee arthroplasty or osteotomy or planned knee surgery in the subsequent 6 months; presence of another condition affecting lower limb function; current or previous (prior 6 months) use of shoe inserts, braces, or customized shoes from a health professional; inability to walk unaided; body mass index of 36 kg/m2 or greater; or self-reported pathology or pain in the ankle or foot. Randomization and Interventions Participants were randomly assigned in random permuted blocks of 6 to 12, stratified by radiographic severity (KellgrenLawrence grade 2, 3, or 4). The randomization schedule was prepared by an independent biostatistician; concealed in consecutively numbered, sealed opaque envelopes by an independent research assistant; and stored in a centrally accessible and locked location. A researcher who was not involved in enrollment or outcome assessment accessed the schedule. Participants were blinded to allocation. Unloading shoes were visually similar to conventional shoes (Appendix Figure), and model names were removed to ensure that the shoes could not be identified. Participants recorded which group they believed they were allocated to (after being fitted with shoes and at 6 months), and the James blinding index was used to assess blinding success (22). Because primary and secondary outcomes were participant-reported, assessors were also blinded. In addition, the research assistant overseeing data entry and the biostatistician were blinded. Appendix Figure. Intervention (unloading) shoes (top) and comparator (conventional) shoes (bottom). Participants were provided a pair of appropriately sized shoes on the basis of their random assignment and were asked to wear them as much as possible every day (4 hours/day) for 6 months and to avoid changing shoes. Participants were provided the shoes at no cost to themselves and were permitted to keep the shoes regardless of whether they completed the trial. For the intervention, we provided black, commercially available unloading walking shoes (GEL-Melbourne OA) (Appendix Figure, top) with triple-density midsoles (stiffer laterally than medially) and mild (5-degree) lateral-wedge insoles attached to the underside of the sock liners. These shoes significantly reduce indirect measures of load across the medial knee compared with conventional recreational shoes (15, 16). For the comparator group, we provided black, commercially available neutral walking shoes (GEL-Odyssey [ASICS]) (Appendix Figure, bottom) that did not contain the specific design features of the unloading shoes. Adherence was measured by self-reported wear of allocated shoes (hours per day), which was recorded in a logbook for 7 consecutive days each month; overall self-reported adherence over 6 months using an 11-point NRS (with the anchors not worn at all and worn completely as instructed); and a shoe-mounted pedometer (Oregon Scientific PE903) for 7 consecutive days during the fourth week of months 2 and 5 to record the number of daily steps in the trial shoes. Outcomes and Follow-up Participants completed self-reported primary and secondary outcome measures at baseline and 6 months, either electronically or on paper at the University of Melbourne. To minimize missing follow-up data, participants were provided a

Where should we measure waist circumference in clinically overweight and obese youth

50AUD gift voucher for returning completed questionnaires at 6 months. Primary outcomes were valid and reliable self-reported pain and physical function measures recommended for knee osteoarthritis clinical trials (23). Overall average pain with walking over the previous week was measured via an 11-point NRS, with terminal descriptors of no pain and worst pain possible and a minimum clinically important difference (MCID) of 1.8 units (24). Difficulty with physical functioning over the previous 48 hours was measured by the function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC, Likert version 3.1) (25), with total scores ranging from 0 (no dysfunction) to 68 (maximum dysfunction) and an MCID of 6 units (26). Both primary outcomes were also assessed at 3 months (secondary time point). Secondary outcomes included knee pain over the previous 48 hours, assessed with the WOMAC pain subscale (25) (also administered at 3 months, with scores ranging from 0 [no pain] to 20 [maximum pain] and an MCID of 18% improvement from baseline [27]); knee stiffness over the previous 48 hours, evaluated with the WOMAC stiffness subscale (25) (also administered at 3 months, with scores ranging from 0 [no stiffness] to 8 [maximum stiffness] and an MCID of 22% improvement from baseline [27]); intermittent and constant knee pain over the previous week, measured by using the Intermittent and Constant Osteoarthritis Pain questionnaire (28) (scores ranging from 0 [no pain] to 100 [maximum pain] and MCIDs of 18.7 and 18.4, respectively [29]); global change in pain and physical function, assessed with 7-point Likert scales (measured at 3 and 6 months, with terminal descriptors of much worse and much better); health-related quality of life, evaluated with the Assessment of Quality of Life 6D scale (AQoL-6D) (30) (scores ranging from 0.04 [lowest quality] to 1.00 [highest quality] and an MCID of 0.06 units [31]); and physical activity over the previous week, assessed with the Physical Activity Scale for the Elderly (32) (scores ranging from 0 [lowest] to >400 [highest]). Adverse effects of treatment (any problem believed by the participan

Telephone-Delivered Exercise Advice and Behavior Change Support by Physical Therapists for People with Knee Osteoarthritis: Protocol for the Telecare Randomized Controlled Trial

Waist circumference (WC) measurement is a useful tool in the assessment of overweight/obese individuals, but standard measures may miss an apron of ‘overhanging’ fat (termed ‘panniculus’). The objective of this study was to assess whether, in clinically overweight/obese youth, ‘pannicular’ WC better correlates with fat mass than a standard WC measurement.

Special shoes for the management of knee osteoarthritis symptoms

Background Exercise and physical activity are a core component of knee osteoarthritis (OA) care, yet access to physical therapists is limited for many people. Telephone service delivery models may increase access. Objective Determine the effectiveness of incorporating exercise advice and behavior change support by physical therapists into an existing Australian nurse-led musculoskeletal telephone service for adults with knee OA. Design Randomized controlled trial with nested qualitative studies. Setting Community, Australia-wide. Participants One hundred seventy-five people ≥45 years of age with knee symptoms consistent with a clinical diagnosis of knee OA. Eight musculoskeletal physical therapists will provide exercise advice and support. Intervention Random allocation to receive existing care or exercise advice in addition to existing care. Existing care is a minimum of one phone call from a nurse for advice on OA self-management. Exercise advice involves 5-10 calls over 6 months from a physical therapist trained in behavior change support to prescribe, monitor, and progress a strengthening exercise program and physical activity plan. Measurements Outcomes will be measured at baseline and at 6 and 12 months. Primary outcomes are knee pain and physical function. Secondary outcomes include other measures of knee pain, self-efficacy, physical activity and its mediators, kinesiophobia, health service usage, work productivity, participant-perceived change, and satisfaction. Additional measures include adherence, adverse events, therapeutic alliance, satisfaction with telephone-delivered therapy, and expectation of outcome. Semi-structured interviews with participants with knee OA and therapists will be conducted. Limitations Physical therapists cannot be blinded. Conclusions This study will determine if incorporating exercise advice and behavior change support by physical therapists into a nurse-led musculoskeletal telephone service improves outcomes for people with knee OA. Findings will inform development and implementation of telerehabilitation services.

Unloading shoes for osteoarthritis of the knee: protocol for the SHARK randomised controlled trial

What is the problem and what is known about it so far? Guidelines for knee osteoarthritis suggest that physicians provide advice to patients about the proper shoes to wear to help relieve their pain. Shoes that decrease the stress on the knee joint (unloading shoes) are widely available, but it is not clear whether these shoes are effective at improving symptoms in patients with knee osteoarthritis. Why did the researchers do this particular study? To compare the effects of unloading shoes and conventional walking shoes on knee pain and functioning in patients with knee osteoarthritis. Who was studied? 164 adults who had knee osteoarthritis documented on x-rays and pain on most days of the month. How was the study done? The study participants were randomly assigned to wear unloading shoes or conventional walking shoes. The shoes had a similar appearance and were provided to the participants free of charge. The participants were told to wear the shoes as much as possible every day. They answered questions about knee pain and physical functioning at baseline (before wearing the shoes) and after 6 months of wearing the shoes, and they recorded any problems they had while wearing the shoes (such as increased pain). The participants received a

Location of knee pain in medial knee osteoarthritis: patterns and associations with self-reported clinical symptoms

50 gift card if they completed the 6-month questionnaire. What did the researchers find? At baseline, the researchers examined the shoes that study participants wore most often and found that most of the shoes were old (the average age was 3.4 years) or worn out. Both groups showed the same amount of change in pain and physical functioning after wearing their assigned shoes for 6 months, and these measurements did not differ between the unloading shoe and conventional shoe groups. Similar numbers of participants in both groups recorded problems with wearing the shoes. Although ankle and foot pain were reported more often in the unloading shoe group than in the conventional shoe group, the number of patients who stopped wearing the shoes was similar in both groups. What were the limitations of the study? Only one model of unloading shoe was studied in this trial, so the results of this study may not apply to unloading shoes from another manufacturer. What are the implications of the study? Unloading shoes provided effects similar to those of conventional walking shoes among adults with knee osteoarthritis. Patients with knee osteoarthritis may find it helpful to buy a new pair of walking shoes if the shoes they wear regularly are old or show signs of wear and tear.